Site Quality Assurance Engineer II

ZOLL Medical•Deerfield, IL

1d•Hybrid

About The Position

The Site Quality Assurance Engineer II provides technical support for manufacturing and operational quality activities, with a focus on investigations, process improvement, and quality system effectiveness. This role leads manufacturing quality investigations, partners with Manufacturing, Operations, Engineering, Supply Chain, and Regulatory teams, and drives actions that improve process performance, product quality, and compliance with regulatory and company standards.

Requirements

Bachelor’s degree in Engineering or a related technical discipline.
5 plus years of experience in quality engineering, manufacturing quality, or a related engineering role, preferably in the medical device industry.
Demonstrated experience leading investigations, root cause analysis, and manufacturing quality improvement activities.
Working knowledge of manufacturing quality systems, nonconformance management, and CAPA processes.
Knowledge of statistical process control, process capability analysis, and data-driven problem solving.
Experience collaborating in cross-functional environments to resolve technical and quality issues.
Strong written and verbal communication skills, with the ability to clearly present findings and recommendations to technical stakeholders.
Ability to work effectively in a hybrid or on-site environment while collaborating across cross-functional teams.

Nice To Haves

Experience in medical device manufacturing, process validation, equipment qualification, and new product introduction support.
Familiarity with FDA Quality System requirements, ISO 13485, and medical device regulatory requirements.
Experience supporting MRB activities, nonconformance systems, and manufacturing CAPA investigations.
Knowledge of statistical analysis tools and manufacturing quality methodologies.
ASQ Certified Quality Engineer or similar certification is a plus.

Responsibilities

Lead investigations into manufacturing and process quality issues, including root cause analysis, data review, and development of recommendations to address quality concerns.
Support Material Review Board activities and nonconforming material resolution, including documentation, disposition support, and coordination with cross-functional teams.
Lead manufacturing CAPA and nonconformance investigations, including documentation, cross-functional coordination, and follow-up of corrective actions.
Analyze yield, scrap, rework, and process capability data to identify trends, recurring issues, and opportunities for manufacturing quality improvement.
Support manufacturing process validation, equipment qualification, and new product introduction readiness activities through review of documentation and participation in related quality assessments.
Collaborate with Manufacturing, Operations, Engineering, Supply Chain, Supplier Quality, and Regulatory teams to resolve site quality issues and implement effective solutions.
Participate in internal and external audits, inspection readiness activities, and regulatory compliance efforts to support adherence to applicable quality system requirements and internal procedures.
Ensure site quality activities are performed in compliance with applicable regulatory requirements, quality system standards, and internal procedures.
Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records.
Contribute to continuous improvement initiatives related to manufacturing quality, process performance, and quality system effectiveness.